PoreStar Patient Specific Implant
FDA 510(k) clearance K171037 · decided 2017-12-27
Clearance details
- K-number
- K171037
- Device name
- PoreStar Patient Specific Implant
- Applicant
- Anatomics Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-04-06
- Decision date
- 2017-12-27
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- JOF
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- St Kilda, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| StarPore (K200532) | Anatomics Pty, Ltd. | 2020-06-02 |
| MEDPOR CUSTOMIZED SURGICAL IMPLANT (K083621) | Porex Surgical, Inc. | 2009-02-03 |
| SILMAX CONTOUR CARVING BLOCK IMPLANT (K002629) | Pillar Surgical, Inc. | 2000-11-20 |
| BIOSPONGE STAPES PISTON (K771726) | Xomed, Inc. | 1977-09-26 |
| BIOSPONGE RECONSTRUCTION DISCS (K771727) | Xomed, Inc. | 1977-09-26 |
Recalls involving this device
No recalls on record reference this clearance.